Nutritional Intervention With Table Olives in Healthy Volunteers (BIOLIVA)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase: Completed; Phase 2; Phase 1

Conditions: Biological Availability; Healthy; Functional Food; Nutrition Physiology; Nutritional Intervention

Treatments: Other: Table Olives

Study type: Interventional

Funder types: Other

Identifiers

NCT03886597

IIBSP-OLI-2016-23

Details and patient eligibility

About

Olives and olive oil are typical components of the Mediterranean diet being part of its cultural and gastronomic heritage. Since ancient times, olives have been used either for both, oil extraction or whole fruit consumption as table olives. Olive oil stands out from both the nutritional and the health point of view. However, the effect of table olives consumption remains almost unknown. The beneficial properties of olive oil have been initially ascribed to the high concentration of oleic acid. Nowadays, these positive effects have been attributed also to minor compounds such as polyphenols or pentacyclic triterpenes. Table olives contain a higher amount of both polyphenols and pentacyclic triterpenes than their oil, with the same healthy fatty acid profile. Therefore, the present intervention aims at investigating the pharmacokinetic of polyphenols and pentacyclic triterpenes after a single olive intake as well as the assessment of the effect of the consumption of olives during 30 days on the overall health status playing particular attention to the anti-inflammatory, antioxidant and cardiovascular biomarkers.

Enrollment: 58 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index between 19 and 30 kg/m2.
• Healthy on the basis of physical examination and routine biochemical and hematological laboratory determinations.
• Free acceptance to participate in the study by obtains signed informed consent.

Exclusion criteria

• Smoking.
• Alcohol or drug abuse.
• Heavy consumer of stimulating beverages (>5 coffees, teas, chocolate or cola drinks per day) and grapefruit juice.
• Background of allergy, idiosyncrasy or hypersensitivity to drugs.
• Intake of any medication within 2 weeks prior taking the study intervention (except for use of paracetamol in short-term symptomatic treatments), including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), or any enzymatic inductor or inhibitor within 3 months before the drug administration.
• Positive serology for hepatitis B, C or HIV.
• Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.
• Having undergone major surgery during the previous 6 months.
• Pregnancy or lactation status (if applied).
• Participation in another clinical trial during the 3 months preceding the drug administration.
• Donation of blood during the 4 weeks preceding the drug administration.
• Acute illness four weeks before drug administration.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 4 patient groups

60 Arbequina Table Olives

Experimental group

Description:

Pharmacokinetics Study

Treatment:

Other: Table Olives

Other: Table Olives

Other: Table Olives

120 Arbequina Table Olives

Experimental group

Description:

Pharmacokinetics Study

Treatment:

Other: Table Olives

Other: Table Olives

Other: Table Olives

60 Table Olives

Experimental group

Description:

Table Olives Nutritional Intervention

Treatment:

Other: Table Olives

Other: Table Olives

Other: Table Olives

Control

No Intervention group

Description:

Control of Table Olives Nutritional Intervention